Surgical methods for breast reconstruction or augmentation

ABSTRACT

Methods for breast reconstruction and augmentation are provided which may reduce the incidence of capsular contracture. Methods for treating an encapsulated breast and reducing potential for capsular contracture in the breast are also provided.

BACKGROUND

The present invention generally relates to surgical methods, and morespecifically relates to breast augmentation, reconstruction and breastimplant revision surgical methods.

Prostheses or implants for augmentation and/or reconstruction of thehuman body are well known. Capsular contracture is a complicationassociated with surgical implantation of prostheses, particularly withsoft implants, and even more particularly, though certainly notexclusively, with fluid-filled breast implants.

When a foreign material is implanted in a human body, the immune systemattempts to isolate the material by forming a collagen-based capsule.After time, the capsule may contract, becoming hardened and painful, andpossibly requiring surgical correction. This phenomenon is known as“capsular contracture” and is a significant adverse event for breastimplant patients.

Capsular contracture is believed to be a result of the immune systemresponse to the presence of a foreign material in the body. A normalresponse of the body to the presence of a newly implanted object, forexample a breast implant, is to form a capsule of tissue, primarilycollagen fibers, around the implant. Capsular contracture occurs whenthe capsule begins to contract and squeeze the implant. This contracturecan be discomforting or even extremely painful, and can cause distortionof the augmented or reconstructed breast. The exact cause of contractureis not known. However, some factors may include bacterial contaminationof the implant prior to or after placement, submuscular versussubgladular placement, and smooth surface implants versus texturedsurface implants, and bleeding, pocket size or trauma to the area. It isalso known that contracture rates are increased in patients following animplant replacement after removal for an initial contracture as well asin patients undergoing breast reconstruction following mastectomy orradiation therapy for breast cancer.

A conventional procedure for treating a contracted capsule is known as acapsulectomy, in which capsular tissue is removed from the breast eitherwith the implant or following removal of the implant. This is generallyperformed once contracture has reached a severity which considerablyaffects the look and feel of the breast or causes significant discomfortto the patient. The procedure involves gaining entry to the breastinterior by way of a surgical incision and removing the implant and theentire capsule of fibrous tissue surrounding the implant. Most commonly,this capsule is removed whole, to eliminate the chance of a recurrence.Capsule removal is an invasive procedure which involves removal ofhealthy tissue from the already compromised breast, as it is a goal toremove all of fibrous capsule tissue. Most often, because of thesignificant loss of tissue, a new implant must be introduced into thebreast cavity. When a patient has thin tissue and not sufficient breasttissue and/or breast glandular tissue, removing the capsular tissue canresult in severe deficiency of remaining breast tissue, which may leadto severe rippling, visibility and possibly even skin necrosis due topoor blood supply, when the new implant is placed. In some cases thecapsule is not entirely removed following explantation of the implant,but is surgically scored to release the tension of the contractedcapsule.

There is still a need for better methods for reducing the occurrence orreoccurance of capsular contracture in patients receiving breastimplants.

SUMMARY

Surgical methods and devices are provided for breast reconstruction andaugmentation which reduced potential for capsular contracture.

In accordance with one aspect of the invention a method foraugmenting/reconstructing a breast in a patient generally comprises thesteps of introducing a first prosthesis having a first surface textureinto a breast, and allowing the first prosthesis to remain in the breastfor a time sufficient for a tissue capsule to form about the firstprosthesis. The first prosthesis is then removed from the breast to forma breast cavity.

A second prosthesis, having a second surface texture is then introducedinto the breast cavity and the preexisting tissue capsule is disruptedand reduced in severity over time. In one aspect of the invention, thesecond surface texture has a structure which stimulates tissueintegration from preformed capsular tissue. In some instances, thesecond surface texture may be a non-bioresorbable surface, for example,a porous silicone elastomeric surface having a highly interconnected,open-celled structure.

In one aspect of the invention, the second surface texture has a texturedifferent from the first surface texture. The first surface texture maydiffer from the second surface texture in terms of average pore size,pore interconnectivity, pore density and/or any and other structuraldistinction which will result in disruption of capsular tissue formedadjacent the first texture.

For example, in some embodiments, the first surface texture may have arelatively small average pore size and/or with pores lackinginterconnectivity between pores, for example, the pores being only opento the outside or, alternatively, the first surface texture may have nosignificant pores at all. In this case, the second surface texture mayhave relatively larger average pore size and/or greaterinterconnectivity between pores, for example, pores which generallyconnect with each other below the surface of on the implant, forexample, pores forming something of a honeycomb-like structure.

For example, in some embodiments, the first implant may be relativelysmooth or have an average pore size of no greater than about 200 μm toabout 500 μm, and the average pore size of the second surface texture isgreater than about 600 μm with pores interconnecting with each otherallowing for tissue integration and connectivity between pores.

The first prosthesis may be an inflatable prosthesis, for example, aconventional, inflatable tissue expander. Such inflatable prosthesesoften include a port and tubing, or other structure for facilitatinginflation of the implant in situ. The first prosthesis may be inflatedover a period of time to allow for tissue expansion, prior to the stepof removing the tissue expander. The first prosthesis is left in placeuntil such time as a capsule forms about the surface of the prosthesis.In some embodiments, the prosthesis remains in place for a period ofweeks or months, for example, between about 4 weeks and about 6 months.

The second prosthesis may be a conventional breast implant, for example,a prosthesis intended as a “permanent” implant. The second prosthesismay be a fillable, inflatable breast implant, or a silicone gel filledbreast implant. The second prosthesis is implanted into the capsuleremaining in the breast after removal of the first prosthesis.

In another aspect of the invention, a device useful for treatingcapsular contracture in a breast is provided wherein the devicecomprises a breast implant having a textured surface that, whenimplanted into a breast cavity defined by a preformed, intact, organizedcollagen capsule, results in remodeling and/or disruption of thepreformed intact collagen capsule to result in a softer, less organizedcapsule less likely to contract had the primary implant been left inplace. The textured surface of the device is, in some embodiments, anon-bioresorbable porous silicone surface defined by open-celled,interconnected pores having an average pore size of at least about 400μm, for example, at least about 500 μm, for example, greater than about600 μm, or larger.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more readily understood and appreciated withreference to the following Detailed Description when considered inconjunction with the accompanying Drawings of which:

FIG. 1A is a 5× image taken from an intact, capsule of a maleSprague-Dawley rat, the capsule having been formed about a smoothsurface primary implant.

FIG. 1B is a 5× image taken from a capsule of a male Sprague-Dawley rat,the capsule having been “remodeled” and less likely to contract, usingmethods and devices of the present invention.

DETAILED DESCRIPTION

In a broad aspect of the invention, methods are provided forreconstructing or augmenting a breast in a human patient, wherein themethods result in reduced occurrence of capsular contracture relative toconventional methods or of providing a surface structure whichstimulates the remodeling of the pre-existing capsule to a less surfacealigned collagen capsule structure less prone to contracture.

The present methods are useful in various breast surgical settings,including primary reconstruction procedures, e.g. the replacement ofbreast tissues damaged by trauma, disease (for example, breast cancer),and failed anatomic development (tuberous breast deformity); revisionand reconstruction procedures, e.g. the revision or correction of aprevious breast reconstruction surgery; and primary augmentationprocedures, e.g. aesthetic augmentation to change the size, form, andfeel of the breasts.

In an exemplary embodiment, the methods generally comprise the steps ofintroducing a first prosthesis, for example, a tissue expander, having afirst surface texture, into a breast and forming a breast cavity of adesired volume by inflating the tissue expander while in the breast. Thefirst prosthesis is removed from the breast and a second prosthesis,having a second texture different from the first texture, is implantedinto the breast cavity.

For the sake of simplicity, the present disclosure will generally referto the first prosthesis as a tissue expander or primary implant,temporary prosthesis, or temporary breast implant based on a planned ormedically required removal, and the second prosthesis as a breastimplant or permanent breast implant; however, it must be appreciatedthat the present invention is not limited to this particularcombination.

If the device is a tissue expander or primary implant, it is left toremain in the breast for a sufficient length of time to expand thetissue surrounding the tissue expander. The inflation may beaccomplished by incrementally and gradually inflating the expander overa period of time, for example a period of weeks or months, as isconventional in the field of breast reconstructive surgical procedures,to allow safe, gradual growth of tissue and enlargement of the pocket orcavity to be formed upon removal of the tissue expander.

In some breast augmentation/reconstruction procedures, a deflated,rolled tissue expander is positioned in either the subglandular orsubpectoral position and the tissue expander is inflated by introducinga suitable inflation medium, such as saline solution for example,through a tissue expander inflation lumen into the interior of thetissue expander. The tissue expander is then filled with a sufficientamount of fluid to cause the tissue expander to expand the tissue andcreate the desired pocket for the second prosthesis, for example, apermanent implant.

In some embodiments, the tissue expander is inflated to a size aboutequivalent to the size of the expected permanent prosthesis. In otherembodiment, the tissue expander is inflated to a size somewhat largerthan the expected permanent prosthesis size in order to cause the tissueexpander to create a pocket large enough to accommodate the secondimplant. By way of example, if a 400 cc permanent implant is desired tobe placed, the tissue expander may be inflated to 500 cc to 700 cc orgreater to assure that the tissue expander dissects the plane all theway to the margin defined in all directions by the circumferentialmammary ligament.

In one embodiment of the invention, the tissue expander is allowed toremain in the body long enough to expand the space and create asufficient pocket for the subsequent device implant. This may take aperiod of 4 weeks or more, for example, 6 weeks, 10 weeks, 12 weeks or16 weeks. For example, the expander is left in place and graduallyexpands the dissected tissue pocket. That is, the tissue expander isperiodically filled further to cause tissue to propagate therebycreating a larger space. The expander is left in place for the amount oftime required to achieve a sufficient pocket. During this time a capsuleis formed around the tissue expander.

Once the desired pocket size is achieved, the tissue expander issurgically removed from the breast. The capsule is generally formed ofwell-organized, fibrous collagen tissue interfacing and sometimesintegrated into the external surfaces of the expander. Removal of theexpander leaves a breast cavity, or pocket, defined by the tissuecapsule. In some instances, a partial capsulectomy is performed,removing a portion of the capsule when the expander is removed from thebreast. In other instances, the surgeon leaves as much of the capsuleintact as possible.

After removal of the expander, a breast prosthesis is then introducedinto the breast cavity, for example, into the tissue capsule that wasformed about the tissue expander. The breast prosthesis has a secondsurface texture that is different from the texture of the tissueexpander. For example, the first prosthesis, e.g. tissue expander, mayhave a first texture defined by or characterized by a smooth surface, ora closed cell silicone surface (pores open on one side to the outside)having an average pore size of between about 200 μm and about 500 μm,and the second prosthesis may have second texture defined by orcharacterized by a an interconnected open-celled silicone surface havingan average pore size of greater than 500 to 600 μm.

After being implanted into the breast cavity defined by the intactcapsular tissue with characteristic highly aligned collagen fibers, thesecond surface texture causes a significant change in the existingcapsular tissue resulting in tissue ingrowth into the prosthesis anddisruption of the previous collagen fiber alignment around thecircumference of the implant. For example a clinically significantchange occurs in the preexisting capsular tissue, in that the highlyaligned collagen fibers of preexisting capsule that were adjacent to theimplant become less aligned and parallel to the circumference of theimplant and therefore are less likely to contract exert forces leadingto constriction of the implant and hardening of the implant over time.“Remodeled” capsular tissue is defined herein as organized, preexistingcapsular tissue which has, over time, become less organized, forexample, contains less linearly aligned and organized collagen fibersencircling the implant, and has become more cellular relative to thepreexisting capsule structure. Such a remodeled capsule is softer, moreintegrated with the implant surface, and has a reduced potential forcapsular contracture. Such remodeling of capsular tissue may be in theform of enhanced tissue ingrowth of newly formed cells and collagenfibers into the second prosthesis surface.

In another aspect, methods are provided for reducing, disrupting orotherwise ameliorating the severity of a pre-existing, organized capsulesurrounding an implant, for example a smooth or moderately texturedpermanent prosthesis. For example, in some embodiments the invention,the methods comprise treating capsular contracture in a breast having anoriginal implant by removing the original implant leaving at least someof the contracted tissue in place in the body and implanting a newimplant having a texture effective at stimulating the remodeling of theexisting capsule structure.

After a mature capsule has developed, the implant is surgically removedthrough an incision, and a replacement prosthesis is placed inside thepre-existing capsule. The incision is closed such that the implant ispositioned inside the pocket created by the pre-existing capsule. Thenew, replacement prosthesis has an interconnected, open-cell surfacetexture which stimulates remodeling of the capsule, forming a lesssevere, more integrated remodeled capsule about the new implant having adisorganized collagen structure less likely to result in contracturerelative the original capsule. Other advantages of the remodeled capsuleinclude a softer-feeling implant and reduced need for capsulectomy(capsule removal) or capsulotomy (capsule scoring) following explanationof the first implant.

In another aspect of the invention, a device useful for treatingcapsular contracture in a breast is provided, wherein the devicecomprises a breast implant, for example, a silicone gel filled or salinefilled inflatable breast implant, having a textured surface that, whenimplanted into a breast cavity defined by a preformed, intact, organizedcollagen capsule, results in remodeling and/or disruption of thepreformed intact collagen capsule to result in a softer, less organizedcapsule less likely to contract had the primary implant been left inplace. The textured surface of the device is, in some embodiments, anon-bioresorbable porous silicone surface defined by open-celled,interconnected pores. In some embodiments, the average pore size of thetextured surface is between about 400 μm to about 800 μm, or greater,for example, up to about 1.0 mm, or greater. The pores are preferablyhighly interconnected and/or include other structure for promoting cellingrowth and disruption of alignment of collagen fibers over time. In aspecific embodiment, the textured surface has an average pore size ofgreater than about 600 μm.

Remodeling the pre-existing capsule, with organized collagen fibers, toa softer, disorganized collagen fiber structure may be achieved with aninterconnected open-cell texture implant described in certaincommonly-owned patent applications, and/or made by by a variety ofmethods, for example, such as those devices and methods disclosed incommonly-owned U.S. patent application Ser. No. 13/104,811, filed 10 May2011, U.S. patent application Ser. No. 13/246,568, filed 27 Sep. 2011,U.S. patent application Ser. No. 13/104,888, filed 10 May 2011, U.S.patent application Ser. No. 13/104,395, filed 10 May 2011, and U.S.patent application Ser. No. 13/247,835, filed 30 Sep. 2011, the entiredisclosure of each of these applications being incorporated herein bythis specific reference.

EXAMPLE 1A Capsule Formation in a Laboratory Animal

A male Sprague-Dawley rat, approximately 250 g, was implanted with asmooth textured mini-tissue expander along the dorsal surface. Thetissue expander was inflated to 6 ml. After 6 weeks, the implant and thesurrounding tissue were removed, processed and stained with hematoxylinand eosin to identify gross tissue morphology. FIG. 1A is a 5× image ofintact capsule tissue formed about the mini-tissue expander taken fromthe rat. The capsule tissue 12 can be clearly seen in this picture as asmooth, thick band of collagen fibers adjacent the tissue expander 16.The capsule is composed mainly of parallel, organized collagen fibers.If left to remain in place, highly organized fibrous capsules such asthe one shown in FIG. 1A, have greater potential to become contractedand hardened over time, relative to less organized, more integratedcapsules such as the “remodeled” capsule shown in FIG. 1B and describedin the following Example 1B.

EXAMPLE 1B Preexisting Capsule Remodeling in a Laboratory Animal

A male Sprague-Dawley rat, approximately 250 g, was implanted with asmooth textured mini-tissue expander along the dorsal surface, as inExample 1A. The mini-tissue expander was inflated to 6 ml, and after 6weeks, the mini-expander was removed and replaced by a textured,gel-filled (4 ml) mini-implant. The mini-implant had a surface texturethat featured open, interconnecting pores. The mini-implant was placedinside the capsule created by the tissue expander. After 8 weeks, themini-implant and the surrounding tissue were removed, processed andstained with hematoxylin and eosin to identify gross tissue morphology.FIG. 1B is a 5× image of remodeled capsule tissue 18 formed about themini-implant 20 taken from the rat. The original capsule is no longervisible; what can be seen is the extensive tissue interaction with theopen, interconnected pore texture of the implant 20.

It can be seen from FIG. 1B that the resulting tissue ingrowth patternreflects the textured surface of the implant and shows significanttissue/material interaction. The tissue itself is composed ofdisorganized collagen fibers and contains numerous cell bodies.

This “remodeled” capsular tissue is less likely to contract over time.

EXAMPLE 2 Capsule Remodeling in an Breast Reconstruction Patient toTreat Capsular Contracture

A 51 year old woman presents with encapsulated breasts arising frombilateral mastectomy and implant reconstruction. The implants are smoothsurface saline implants. While initially the reconstructions were“good,” over the years the breasts became harder, painful, and changedshape.

The physician removes the smooth surface implants from the breasts,leaving the capsular tissue largely intact. The physician implants newtextured silicone implants into the pocket formed by the capsulartissue.

Although substantially the entire capsule of collagen-based, organizedtissue fibers is left in the breasts, the capsular tissue, over time, isremodeled and reorganized by the interaction with the surfaces of thetextured implants. Three years later, the breasts of the woman are softand appear natural; the capsular tissue has not hardened and contractedeven eight years later.

EXAMPLE 3 Breast Reconstruction in a Mastectomy Patient to ReducePotential for Contracture

At age 26, the patient was diagnosed with Ductal Carcinoma in Situ.Having seen other family members battling cancer, the patient made thedecision to undergo a bilateral mastectomy. At the time of themastectomy procedure, the patient chose not to have immediatereconstructive surgery.

Four years later, the patient decides to have implants placed. Becausethe skin of the patient's chest is taught and thin, the physiciandecides to gradually form a breast cavity for receiving a permanentprosthesis, using a tissue expander. The physician implants anuninflated tissue expander, having a textured surface with an averagepore size of about 400 μm. Over a period of ten weeks, the physicianperiodically introduces fluid into the expanders to reach a final volumeof 500 cc per expander. At this time, capsular tissue has formed aroundthe expanders.

The physician removes the expanders, leaving as much of the capsulartissue intact as possible. The physician then implants permanentprostheses into the pockets formed by the capsular tissue. The permanentprostheses are saline implants having surface texture defined by anaverage pore size of about 700 μm.

The capsular tissue becomes disrupted and disorganized as it remodelsand integrates into the new prosthesis that stimulate tissue integrationwith reduced capsule formation. Five years later, the breasts remainsoft and natural in appearance as a result of the remodeling of thepreformed capsule in response to the new texture.

Unless otherwise indicated, all numbers expressing quantities ofingredients, properties such as molecular weight, reaction conditions,and so forth used in the specification and claims are to be understoodas being modified in all instances by the term “about.” Accordingly,unless indicated to the contrary, the numerical parameters set forth inthe specification and attached claims are approximations that may varydepending upon the desired properties sought to be obtained by thepresent invention. At the very least, and not as an attempt to limit theapplication of the doctrine of equivalents to the scope of the claims,each numerical parameter should at least be construed in light of thenumber of reported significant digits and by applying ordinary roundingtechniques. Notwithstanding that the numerical ranges and parameterssetting forth the broad scope of the invention are approximations, thenumerical values set forth in the specific examples are reported asprecisely as possible. Any numerical value, however, inherently containscertain errors necessarily resulting from the standard deviation foundin their respective testing measurements.

The terms “a,” “an,” “the” and similar referents used in the context ofdescribing the invention (especially in the context of the followingclaims) are to be construed to cover both the singular and the plural,unless otherwise indicated herein or clearly contradicted by context.Recitation of ranges of values herein is merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range. Unless otherwise indicated herein, eachindividual value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context. The use of any and allexamples, or exemplary language (e.g., “such as”) provided herein isintended merely to better illuminate the invention and does not pose alimitation on the scope of the invention otherwise claimed. No languagein the specification should be construed as indicating any non-claimedelement essential to the practice of the invention.

Groupings of alternative elements or embodiments of the inventiondisclosed herein are not to be construed as limitations. Each groupmember may be referred to and claimed individually or in any combinationwith other members of the group or other elements found herein. It isanticipated that one or more members of a group may be included in, ordeleted from, a group for reasons of convenience and/or patentability.When any such inclusion or deletion occurs, the specification is deemedto contain the group as modified thus fulfilling the written descriptionof all Markush groups used in the appended claims.

Certain embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention. Ofcourse, variations on these described embodiments will become apparentto those of ordinary skill in the art upon reading the foregoingdescription. The inventor expects skilled artisans to employ suchvariations as appropriate, and the inventors intend for the invention tobe practiced otherwise than specifically described herein. Accordingly,this invention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

In closing, it is to be understood that the embodiments of the inventiondisclosed herein are illustrative of the principles of the presentinvention. Other modifications that may be employed are within the scopeof the invention. Thus, by way of example, but not of limitation,alternative configurations of the present invention may be utilized inaccordance with the teachings herein. Accordingly, the present inventionis not limited to that precisely as shown and described.

What is claimed is:
 1. A method for reconstructing a breast in apatient, the method comprising the steps of: introducing a firstprosthesis having a first surface texture having no significant pores,into a breast; allowing the first prosthesis to remain in the breast fora time sufficient for an organized tissue capsule to form about thefirst prosthesis; removing the first prosthesis from the breast to forma breast cavity while leaving the organized capsular tissue intact inthe breast; and introducing a second prosthesis into the breast cavity,the second prosthesis having a second surface texture havinginterconnected pores and an average pore size of greater than 600 μm inorder to cause remodeling and/or disruption of said organized capsulartissue.
 2. The method of claim 1 wherein the first prosthesis is aninflatable tissue expander.
 3. The method of claim 1 further comprisingthe step of inflating the second prosthesis after the step ofintroducing the second prosthesis.
 4. The method of claim 1 wherein thesecond texture surface is a non-bioresorbable surface.
 5. A method forreconstructing a breast in a patient, the method comprising the stepsof: introducing a first prosthesis having a first surface texture havingno significant pores, into a breast; allowing the first prosthesis toremain in the breast for a time sufficient for an organized tissuecapsule to form about the first prosthesis; removing the firstprosthesis from the breast to form a breast cavity while leaving theorganized capsular tissue intact in the breast; and introducing a secondprosthesis into the breast cavity, the second prosthesis having a secondsurface texture having interconnected pores and an average pore size ofgreater than 600 μm, in order to cause remodeling and/or disruption ofsaid organized capsular tissue; wherein the second surface texture is aporous, elastomeric silicone surface.
 6. A method for reconstructing abreast in a patient, the method comprising the steps of: introducing afirst prosthesis having a smooth surface into a breast; allowing thefirst prosthesis to remain in the breast for a time sufficient for anorganized tissue capsule to form about the first prosthesis; removingthe first prosthesis from the breast to form a breast cavity whileleaving the organized capsular tissue intact in the breast; andintroducing a second prosthesis into the breast cavity, the secondprosthesis having a second surface texture having interconnected poresand an average pore size of greater than 600 μm in order to causeremodeling and/or disruption of said organized capsular tissue.